A Multicenter Analysis of Levonorgestrel-Intrauterine System (LNG-IUS) Use in the Postpartum Period

NCT ID: NCT01161095

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-01
• Study Completion Date: 2014-05-28

Brief Summary

The primary objective of the investigators study is to determine if there is a difference in continuation rates at six months in women who are randomized to have the Levonorgestrel Intrauterine System (LNG-IUS) inserted at two possible time periods: Immediate (defined as after delivery of placenta to 72 hours postpartum) or Interval (defined as after 6 weeks postpartum).

Detailed Description

The control arm of our study will be women who are randomized to receive LNG-IUS in the Interval time period. The study arm will consist of women randomized to receiving Immediate placement.

The investigators hypothesize that Immediate placement of IUD in the postpartum period will result in a 20% decrease in continuation rates at six months compared to Interval placement.

Secondary outcome measures that we will obtain include:

• Pain at the time of placement
• Postpartum Depression
• Breastfeeding status
• Postpartum weight retention
• Expulsion Rates
• Bleeding Profile
• Uterine Infection(Endometritis)

Conditions

Contraception; Postpartum Period

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate

LNG-IUS insertion within the timeframe of delivery of the placenta to 72 hours postpartum

Group Type: EXPERIMENTAL

LNG-IUS

Intervention Type: DEVICE

Mirena (Bayer)- Levonorgestrel-Intrauterine System

Interval

LNG-IUS insertion after 6 weeks postpartum

Group Type: ACTIVE_COMPARATOR

LNG-IUS

Intervention Type: DEVICE

Mirena (Bayer)- Levonorgestrel-Intrauterine System

Interventions

LNG-IUS

Mirena (Bayer)- Levonorgestrel-Intrauterine System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All women >37 weeks gestation who desire LNG-IUS for postpartum contraception who do not have a contraindication as described below will be offered participation in our study.

Exclusion Criteria

Contraindications to the LNG-IUS include:

• Pregnancy or suspicion of pregnancy
• Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
• Postpartum endometritis within the past 3 months
• Known or suspected uterine or cervical neoplasia or unresolved, abnormal pap smear
• untreated acute cervicitis or vaginitis including bacterial vaginosis or other lower genital tract infections
• acute liver disease or liver tumor
• hypersensitivity to any component of the product
• known or suspected carcinoma of the breast

Any of these conditions would exclude the patient from receiving these forms of contraception in our study.

In addition the following intrapartum findings, the following would exclude the patient:

• Delivery <37 weeks
• Intrapartum chorioamnionitis (defined as maternal fever >100.4 and two of the following conditions: Maternal leukocytosis (greater than 15,000 cells/cubic millimeter), Maternal tachycardia (greater than 100 beats/minute), Fetal tachycardia (greater than 160 beats/minute), Uterine tenderness, Foul odor of the amniotic fluid
• Postpartum Hemorrhage (defined as >500cc EBL for spontaneous vaginal delivery or >1000cc for cesarean delivery)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

United States Naval Medical Center, Portsmouth

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Arkansas for the Medical Sciences

Little Rock, Arkansas, United States

Naval Medical Center

Portsmouth, Virginia, United States

Countries

United States

Other Identifiers

NMCP.2010.0074

Identifier Type: -

Identifier Source: org_study_id